AB1191 SAFETY PROFILE OF COVID VACCINES IN ARTHRITIS PATIENTS. A TWO-CENTERS STUDY.
Authors: V. Rella, G. Busto, C. Rotondo, M. Fornaro, R. Colia, A. Corrado, F. Iannone, F. P. Cantatore
Journal: Annals of the Rheumatic Diseases (2022)

Background Coronavirus 19 disease (COVID-19) represents the most important pandemic of the last century. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection has produced more than 170 million cases and more than 3 million deaths. Due to the easy spread of the infection and the possibility of serious clinical manifestations, the role of anti-COVID 19 vaccination is essential. Vaccines with different mechanisms of action have been developed: mRNA-based, such as Biontech-Pfizer and Moderna, and viral vectored, such as AstraZeneca and Janssen. Despite possible adverse events, benefits afforded by these vaccines significantly outweigh potential risks associated with their administration in the general population. Objectives This study aimed to evaluate incidence and severity of adverse events (AEs), secondary to vaccination, in patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Spondyloarthritis (SpA), immune-mediated diseases treated with immunomodulating drugs, by administering a questionnaire. Methods 294 patients (201 f and 93 m) were enrolled with a diagnosis of arthritis (RA 28%, PsA 43%, SpA 28%). Results Of the 294 enrolled patients, 107 underwent COVID vaccination, 73% with Biontech-Pfizer vaccine, 20% Astrazeneca and 6% Moderna. 50% of patients completed the entire vaccination cycle. 46% of patients presented AEs after the first dose of vaccine (45% of vaccinated with Biontech-Pfizer; 48% of vaccinated with Astrazeneca, 33% of vaccinated with Moderna). The most frequently observed AEs are: pain at the injection site (17%), fever (13%), headache (12%), myalgia (12%), fatigue (7.5%). Only 2.9% of patients had arthritis flares. The greatest trend of AEs was observed in patients with PsA (48%), and RA (26%). 32% of patients receiving the second dose of vaccine presented AEs (40% Moderna, 32% Biontech-Pfizer). The most frequently observed AEs after the second dose are: pain at the injection site (4.7%), fever (9%), headache (2.8%), myalgia (6%). No patient had arthritis flare after the second dose. The greatest trend of AEs was observed in patients with SpA (66%). Only 11% of patients presented AEs after the administration of both doses. Thirteen percent of patients did not follow the clinician’s recommendations for immunomodulatory drug management, provided as per ACR or SIR recommendations. Conclusion The incidence of adverse events in arthritis patients was in line with that of the general population, without presenting serious manifestations, such as thrombosis, and without indicating a preference on the type of vaccine. References [1]Tsai SC, Lu CC, Bau DT, Chiu YJ, Yen YT, Hsu YM, Fu CW, Kuo SC, Lo YS, Chiu HY, Juan YN, Tsai FJ, Yang JS. Approaches towards fighting the COVID‑19 pandemic (Review). Int J Mol Med. 2021 Jan;47(1):3-22. doi: 10.3892/ijmm.2020.4794. Epub 2020 Nov 20. PMID: 33236131; PMCID: PMC7723515. [2]Hodgson SH, Mansatta K, Mallett G, Harris V, Emary KRW, Pollard AJ. What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. Lancet Infect Dis. 2021 Feb;21(2):e26-e35. doi: 10.1016/S1473-3099(20)30773-8. Epub 2020 Oct 27. PMID: 33125914; PMCID: PMC7837315. Disclosure of Interests None declared